GYN DisordersROBYNNCT05496244
ROBYN Study - Robotic Assisted Surgery in Gynecological Indications Compared to Conventional Laparoscopy
An observational study of GYN Disorders, run by Intuitive Surgical.
Trial summary
Robotic Assisted Surgery (da Vinci System) in gynecological indications compared to conventional laparoscopy Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- GYN Disorders
- What is being tested?
- Laparoscopy and Robotic-assisted surgery
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2022to Dec 2030
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients present with gynecological disease that may be treated by surgical intervention
Who may be able to join
- Patient is willing to participate and to comply with the study procedures
- Patient present with gynecological disease that may be treated with surgical intervention
Who cannot join
- Life expectancy for less than 1 year
About this study
Official title: ROBYN Study - Robotic Assisted Surgery in Gynecological Indications Compared to Conventional Laparoscopy - A Prospective, Non-Interventional, Multinational, Post-Market Clinical Investigation
Robotic Assisted Surgery (da Vinci System) in gynecological indications compared to conventional laparoscopy
Read the detailed description
A Prospective, Non-Interventional, Multinational, Post-Market Clinical Investigation
- Conditions
- GYN Disorders
- Being tested
- Laparoscopy, Robotic-assisted surgery
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaparoscopyDevice
Laparoscopic surgery
Robotic-assisted surgeryDevice
Robotic-assisted surgery
| Study group | Role | What they receive |
|---|---|---|
| Epidemiological Section | Consecutive enrollment of patients with indications of interest | |
| Observational Section | Extended data collection on patients treated via conventional laparoscopy or robotic-assisted surgery Receives: Device: Laparoscopy; Device: Robotic-assisted surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe treatment decision
Describe treatment decision for the procedure of choice
Measured: Enrollment Completion
Describe patient outcome
Describe patient outcome from robotic-assisted surgery and conventional laparoscopy by using physiological parameter such as relief or improvement of symptoms, number of complications or number of re-operations and changes in the patient reported quality of life (EQ-5D-5L) between baseline and FU at 12 Months (changes in the score)
Measured: 12 Months
Describe impact of patient factors on outcome
Describe impact of patient factors on outcome by using physiological parameter, such as age, BMI, uterus size, report co-morbidities
Measured: 12 Months
Complications of medical interest
Describe complication of medical interest
Measured: 90 days
Secondary outcomes (4)
Quality of Life Impact per patient reported questionnaires
Describe Quality of Life impact as assessed via patient reported questionnaires; changes in quality of life questionnaires scores between baseline and up to follow-up 12 months will be assessed (EQ-5D-5L on mobility, self-care, usual activities, pain/discomfort, anxiety/depression)
Measured: 12 Months
Describe the impact of surgeon experience on outcome
Describe the impact of surgeon experience on outcome; individual surgeon experience will be collected (self-reported by surgeon) and linked to every performed procedure; descriptive assessment if the reported surgeon experience has an impact on the outcome, e.g. number of reported complications. As surgeon experience, the number of performed procedures per indication and technique (robotic-assisted surgery or laparoscopy will be collected), as well as the overall years the surgeon is performing surgeries.
Measured: 12 Months
Describe the performance and use of Intuitive instruments
Describe the performance and use of Intuitive instruments; information on any device failure or device deficiency will be collected and descriptively assessed
Measured: 12 Months
Describe the performance and use of Intuitive systems
Describe the performance and use of Intuitive systems; information on any device failure or device deficiency will be collected and descriptively assessed
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study startNov 2022 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionDec 2030 (estimated)
Why it stopped: Overall re-assessment of study design
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GYN DisordersStudies of the same condition, open and under way.
- More trials run by Intuitive SurgicalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ingolf Juhasz-Böss, Prof. Dr., Principal investigator, Universitätsklinikum Freiburg, GermanyVincent Lavoué, Prof. Dr., Principal investigator, CHU de Rennes, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496244
- Sponsor's protocol ID
- 1.0
- Acronym
- ROBYN
- Status last verified
- Jun 2023
- First submitted
- 13 Jul 2022
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROBYN Study - Robotic Assisted Surgery in Gynecological Indications Compared to Conventional Laparoscopy - A Prospective, Non-Interventional, Multinational, Post-Market Clinical Investigation
- ClinicalTrials.gov ID
- NCT05496244
- Acronym / sponsor ID
- ROBYN / 1.0
- Conditions
- GYN Disorders
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Overall re-assessment of study design
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- Nov 2022 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 11 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Robotic Assisted Surgery (da Vinci System) in gynecological indications compared to conventional laparoscopy
Detailed description
A Prospective, Non-Interventional, Multinational, Post-Market Clinical Investigation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidemiological Section | – | –Consecutive enrollment of patients with indications of interest |
| Observational Section | – | Device: Laparoscopy, Device: Robotic-assisted surgeryExtended data collection on patients treated via conventional laparoscopy or robotic-assisted surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients present with gynecological disease that may be treated by surgical intervention
Key inclusion criteria (2 listed)
- Patient is willing to participate and to comply with the study procedures
- Patient present with gynecological disease that may be treated with surgical intervention
Key exclusion criteria (1 listed)
- Life expectancy for less than 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LaparoscopyLaparoscopic surgery | Device | Observational Section |
| Robotic-assisted surgeryRobotic-assisted surgery | Device | Observational Section |
Primary outcome
Describe treatment decision
Time frame: Enrollment Completion
Describe treatment decision for the procedure of choice
Describe patient outcome
Time frame: 12 Months
Describe patient outcome from robotic-assisted surgery and conventional laparoscopy by using physiological parameter such as relief or improvement of symptoms, number of complications or number of re-operations and changes in the patient reported quality of life (EQ-5D-5L) between baseline and FU at 12 Months (changes in the score)
Describe impact of patient factors on outcome
Time frame: 12 Months
Describe impact of patient factors on outcome by using physiological parameter, such as age, BMI, uterus size, report co-morbidities
Complications of medical interest
Time frame: 90 days
Describe complication of medical interest
4 secondary outcomes
Quality of Life Impact per patient reported questionnaires
Time frame: 12 Months
Describe the impact of surgeon experience on outcome
Time frame: 12 Months
Describe the performance and use of Intuitive instruments
Time frame: 12 Months
Describe the performance and use of Intuitive systems
Time frame: 12 Months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingolf Juhasz-Böss, Prof. Dr. principal investigator
Universitätsklinikum Freiburg, Germany
Vincent Lavoué, Prof. Dr. principal investigator
CHU de Rennes, France
Questions about this trial
What is this clinical trial studying?
An observational study of GYN Disorders, run by Intuitive Surgical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe treatment decision (time frame: Enrollment Completion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2023; AzTrials last refreshed its copy on 26 Oct 2026.